ClearanceBrief
510(k) K234151 ยท OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue

Isolator Synergy EnCapture Ablation System (EMH)

ApplicantAtriCure, Inc., Mason OH, US
DecisionSubstantially Equivalent, Aug 27, 2024
ReceivedDec 29, 2023
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K234151

No recall in the FDA data names this 510(k).

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.